FDA.reportPublic FDA data

SUGAR, FRUCTOSE, 25 GM, PACKET

Primary DI
00850010197807
Brand
SUGAR, FRUCTOSE, 25 GM, PACKET
Company
QUINTRON INSTRUMENT COMPANY, INC.
Model
QT02900-25-S
Catalog number
QT02900-25-S
Published
2023-03-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
NNIContainer, Specimen, Non-Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NNIContainer, Specimen, Non-SterilePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850010197203PrimaryGS10
00850010197807Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850010197203008500101972038500101972030850010197203
00850010197807008500101978078500101978070850010197807

GMDN Terms#

Term, Definition table
TermDefinition
Breath specimen container IVDA container (e.g., bag, tube) intended to contain a specimen of air exhaled from a patient for subsequent in vitro determination of chemical and/or biological markers (e.g., volatile organic compounds) in the specimen to aid metabolic profiling or the diagnosis of disorders [e.g., lipid peroxidation levels, gastrointestinal H. pylori infection, coronavirus disease (COVID-19) infection]. It may include a port for blowing into the container, an access device (e.g., tubing) to facilitate specimen collection, and/or an adaptor for connection to an analyser. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
874498744
Device count
10
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850010197999BT UPGRADE, CUI, INC POWER SUPPLIESQT06011-UP2025-03-19
00850010197029BAG, GASAMPLER, DISCARD, SINGLE-PATIENTQT00843-PQT00843-P2023-03-15
00850010197036T-CONNECTOR, PLASTICQT00850-PQT00850-P2023-03-15
00850010197050MOUTHPIECE, 20 MM, PLASTICQT00991-PQT00991-P2023-03-15
00850010197142SUGAR, DEXTROSE (GLUCOSE), 75 GM PACKETQT02300-75-SQT02300-75-S2023-03-15
00850010197159SUGAR, Rx, GLUCOSE, 100 GM / 10 OZ, LIQUIDQT02350-100-SQT02350-100-S2023-03-15
00850010197166SUGAR, LACTOSE, LACTEST, 25 GM, PACKETQT02425-SQT02425-S2023-03-15
00850010197173SUGAR, Rx, LACTULOSE, 10G/15ML SYRUPQT02500-10-SQT02500-10-S2023-03-15
00850010197180SUGAR, SUCROSE, 50 GM PACKETQT02600-50-SQT02600-50-S2023-03-15
00850010197197SUGAR, D-XYLOSE, 25 GM, PACKETQT02700-25-SSQT02700-25-S2023-03-15
00850010197203SUGAR, FRUCTOSE, 25 GM, PACKETQT02900-25-SQT02900-25-S2023-03-15
00850010197333BAG, SAMPLE HOLDING 250 ML SINGLE PATIENTQT00842-PQT00842-P2023-03-15
00850010197630EASYSAMPLER ASM, 793275QT01665QT016652023-03-16
00850010197005AlveoSamplerAlveoSamplerQT00827-P2023-03-15
00850010197012GaSampler Bag, Single-PatientQT00830-PQT00830-P2023-03-15
00850010197043GaSampler Kit, Single-Patient, No SubstrateQT00892QT008922023-03-15
00850010197067EasySampler D-Xylose KitQT04203QT042032023-03-15
00850010197074EasySampler, Fructose Kit, 4 TubesQT04204QT042042023-03-15
00850010197081EasySampler, Lactulose Kit, 10 Tubes, RxQT04205QT042052023-03-15
00850010197098EasySampler, Lactose Kit, 4 TubesQT04206QT042062023-03-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800075627520OSUNG MNDOSUNG MND Co., Ltd.NNI2025-11-03
10840165500741StarCLICK 100Starplex Scientific Corp.NNI2025-10-10
10840165500765StarCLICK 100Starplex Scientific Corp.NNI2025-10-10
10840165500802LeakbusterStarplex Scientific Corp.NNI2025-10-10
10840165500567LeakbusterStarplex Scientific Corp.NNI2025-10-07
10840165500581LeakbusterStarplex Scientific Corp.NNI2025-10-07
10840165500604LeakbusterStarplex Scientific Corp.NNI2025-10-07
10840165500628LeakbusterStarplex Scientific Corp.NNI2025-10-07
10840165500642LeakbusterStarplex Scientific Corp.NNI2025-10-07
10840165500680LeakbusterStarplex Scientific Corp.NNI2025-10-07
10840165500703LeakbusterStarplex Scientific Corp.NNI2025-10-07
10827989007731Health Care Logistics, Inc®Health Care Logistics, Inc.NNI2025-09-16
10840165500208HistoplexStarplex Scientific Corp.NNI2025-05-30
10840165500086StarCLICK 100Starplex Scientific Corp.NNI2025-05-28
10840165500109LeakbusterStarplex Scientific Corp.NNI2025-05-28
10840165500123LeakbusterStarplex Scientific Corp.NNI2025-05-28
10840165500147LeakbusterStarplex Scientific Corp.NNI2025-05-28
10840165500161LeakbusterStarplex Scientific Corp.NNI2025-05-28
10840165500185HistoplexStarplex Scientific Corp.NNI2025-05-28
10840165500406LeakbusterStarplex Scientific Corp.NNI2025-05-28
10840165500420LeakbusterStarplex Scientific Corp.NNI2025-05-28
10840165401185LeakbusterPretium Canada Packaging ULCNNI2025-04-29
10840165401406LeakbusterPretium Canada Packaging ULCNNI2025-04-29
00616784802138LabChoice Specimen Bags, Clear, 8" x 10"(20.3 cm x 25.4 cm) , 1.8 milDynarex CorporationNNI2025-04-07
00840117333420LabChoice Specimen Bags with Pouch, 4" x 6" (10.2 cm x 15.2 cm), 1.8 milDynarex CorporationNNI2025-04-07
19120126131452VACUETTEGreiner Bio-One GmbHNNI2025-04-02
00616784802039LabChoice Specimen Bags, 6" x 9" (15.2 cm x 22.9 cm), 1.8 mil, Non-SterileDynarex CorporationNNI2025-03-28
00840117333413LabChoice Specimen Bags, 12" x 15" (30.5 cm x 38.1 cm), 1.8 milDynarex CorporationNNI2025-03-28
10860009784892Ditek Urine Collection CupMedzah IndustriesNNI2025-03-06
10840165400966Starplex Pretium Canada Packaging ULCNNI2025-03-04